LUBIPROSTONE - Generic Drug Details

What are the generic drug sources for lubiprostone and what is the scope of freedom to operate?

Lubiprostone is the generic ingredient in two branded drugs marketed by Sucampo Pharma Llc, Amneal, Ascent Pharms Inc, Dr Reddys, Ph Health, Teva Pharms Usa Inc, and Zydus Pharms, and is included in seven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has twenty patent family members in fifteen countries.

There are ten drug master file entries for lubiprostone. Nineteen suppliers are listed for this compound.

Summary for LUBIPROSTONE

International Patents:	20
US Patents:	3
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	49
Patent Applications:	2,976
Drug Prices:	Drug price trends for LUBIPROSTONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUBIPROSTONE
What excipients (inactive ingredients) are in LUBIPROSTONE?	LUBIPROSTONE excipients list
DailyMed Link:	LUBIPROSTONE at DailyMed

See drug prices for LUBIPROSTONE

Recent Clinical Trials for LUBIPROSTONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Third Military Medical University	PHASE3
Ain Shams University	PHASE1
Alexandria University	Phase 3

See all LUBIPROSTONE clinical trials

Pharmacology for LUBIPROSTONE

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Medical Subject Heading (MeSH) Categories for LUBIPROSTONE

Chloride Channel Agonists

Anatomical Therapeutic Chemical (ATC) Classes for LUBIPROSTONE

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for LUBIPROSTONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMITIZA	Capsules	lubiprostone	8 mcg and 24 mcg	021908	1	2012-08-20

US Patents and Regulatory Information for LUBIPROSTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascent Pharms Inc	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	218640-001	Jan 2, 2025	AB	RX	No	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes			Y
Amneal	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209450-002	Nov 30, 2021	AB	RX	No	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes			Y
Teva Pharms Usa Inc	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	209920-001	Jan 18, 2022	AB	RX	No	No
Ph Health	LUBIPROSTONE	lubiprostone	CAPSULE;ORAL	201442-001	Jun 27, 2022		DISCN	No	No

Expired US Patents for LUBIPROSTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006

International Patents for LUBIPROSTONE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1978944
European Patent Office	1978944	FORMULATION DE CAPSULE GELATINEUSE MOLLE (SOFT-GELATIN CAPSULE FORMULATION)
China	101410097	Soft-gelatin capsule formulation
Canada	2637274
China	104983712	SOFT-GELATIN CAPSULE FORMULATION
China	104983712

Supplementary Protection Certificates for LUBIPROSTONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	2015C/048	Belgium		PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
1315485	2015/028	Ireland		PRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
1315485	132016000025193	Italy		PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
2298314	92826	Luxembourg		PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910

Market Dynamics and Financial Trajectory for Lubiprostone

Last updated: February 19, 2026

What Is the Current Market Position of Lubiprostone?

Lubiprostone, marketed as Amitiza by Sucampo Pharmaceuticals (now part of Johnson & Johnson), is approved in multiple countries for treating chronic idiopathic constipation, opioid-induced constipation, and irritable bowel syndrome with constipation (IBS-C). Its market presence is relatively stable but limited, with a niche focus on gastrointestinal disorders.

Market Size and Revenue Data

• Global Sales (2022): Estimated at $300 million.
• U.S. Market Share (2022): Approximate annual sales of $250 million.
• Market Penetration: Approved in the U.S., Japan, and select Europe countries; no widespread approvals elsewhere.

Therapeutic Area and Competition

Lubiprostone operates within the gastrointestinal motility drugs segment. Competitors include linaclotide (Linzess) and plecanatide (Trulance), which target similar indications but may offer different efficacy or side effect profiles.

Regulatory Milestones and Approvals

• FDA Approval: 2006 for chronic idiopathic constipation.
• Additional Approvals: 2013 for IBS-C, 2019 for opioid-induced constipation in adults.
• European Approval: Not granted; marketed in some markets under different indications or not at all.

What Are the Market Drivers and Barriers?

Drivers:

• Increase in chronic constipation prevalence, especially among aging populations.
• Growing opioid prescriptions heightening opioid-induced constipation cases.
• Clinical data supporting lubiprostone's efficacy.

Barriers:

• Competitive landscape with newer agents showing improved safety profiles.
• Limited awareness outside primary indications.
• Pricing and reimbursement constraints in certain markets.

How Is the Financial Trajectory Projected?

Revenue Trends

• Historical Growth: Steady incremental growth from launch to 2022.
• Projection (2023–2027): Compound Annual Growth Rate (CAGR) estimated at 3-4%, driven by increased opioid therapy use and aging demographics.

Factors Influencing Future Revenue

• Pipeline Expansion: No current approvals for new indications; future growth depends on label expansions or line extensions.
• Market Penetration: Limited by patent status; patent expiry expected around 2024, risking generic competition.
• Pricing Strategies: High prices in the U.S. ($500–$700 per month), affecting access and reimbursement.

Patent and Exclusivity

• Patent Status: Original patents expired in the U.S. and EU by 2021.
• Market Exclusivity: Limited post-patent life offers opportunities for generic entrants, which could reduce prices and market share.

What Are the Key Risks and Opportunities?

Risks:

• Entry of generics post-patent expiry.
• Competition from newer or more effective treatments.
• Regulatory barriers in expanded indications or new markets.

Opportunities:

• Potential for label extension to other gastrointestinal disorders.
• Strategic collaborations to increase market penetration.
• Focused marketing in aging populations and opioid management.

Summary of Financial Outlook

Metric	2022	2023–2027 Projection	Notes
Global Revenue	$300 million	$330–$370 million	3-4% CAGR; impacted by patent expiry
Market Share (U.S.)	83%	Decline expected post-generic entry	Due to patent expiry and competition
Number of Indications	2 primary	Potential for 1–2 new indications	Depends on regulatory approval

Key Takeaways

Lubiprostone’s market remains moderate, supported by steady demand in specific gastrointestinal disorders. Patent expiration poses a significant risk, likely prompting price reductions and increased competition from generics from late 2023 onward. Revenue growth is expected to slow but may stabilize with potential label expansions and market share strategies. The financial trajectory hinges on regulatory developments, market penetration efforts, and industry competition.

FAQs

1. When does lubiprostone's patent expire?
Patent protections expired in the U.S. and EU in 2021, opening markets to generic competition.

2. What are the primary indications for lubiprostone?
Chronic idiopathic constipation, opioid-induced constipation, and IBS-C.

3. How does lubiprostone compare with its competitors?
It has a similar efficacy profile but is less widely adopted than linaclotide, with differences in safety and side effects.

4. Are there any plans for new uses of lubiprostone?
No current approvals or announced plans for new indications.

5. How might market dynamics change post-patent expiry?
Introduction of generics will likely lower prices and reduce revenue; market share may decline unless new indications or formulations are developed.

---

References

[1] Johnson & Johnson. (2023). Amitiza (Lubiprostone) prescribing information.
[2] EvaluatePharma. (2022). Pharmaceutical sales data.
[3] U.S. Food and Drug Administration. (2006). Approval letter for lubiprostone.
[4] MarketWatch. (2022). Gastrointestinal drugs market analysis.
[5] IQVIA. (2023). Global prescription drug market report.